Allergy Relief 24hr
NDC 73226-001
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Allergy Relief 24hr is a ANDA-approved product labeled by Vitesse Pharma Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 73226-001 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
73226-001
Proprietary Name:
Allergy Relief 24hr
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
73226
Product Label ID:
FDA Application Number: [6]
ANDA211551
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
07-02-2019
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
8 MM
Imprint(s):
X;X
Score:
2
Code Structure Chart
Product Details
What is NDC 73226-001?
The NDC code 73226-001 is assigned by the FDA to the product Allergy Relief 24hr. This pharmaceutical product is labeled by Vitesse Pharma Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 73226-001-00. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Adults 65 years of age and older■ ask a doctoradults and children 12-64 years of age ■ take 1 tablet (5 mg) once daily in the evening
■ do not take more than 1 tablet (5 mg) in 24 hours
■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age■ take ½ tablet (2.5 mg) once daily in the evening
■ do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age■ do not useconsumers with kidney disease■ do not use(Note: Age ranges are bolded in the draft container labeling for tablet bottle)
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA)
- LEVOCETIRIZINE (UNII: 6U5EA9RT2O) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 855172 - levocetirizine dihydrochloride 5 MG Oral Tablet
- RxCUI: 855172 - levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Levocetirizine
Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
